Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!
**Major accountabilities**:
- To support management of operational processes in ensuring compliance with Sandoz global/local procedures, national and international regulations/standards/guidelines for pharmacovigilance of Sandoz marketed and investigational products -Manage collection, processing, documentation, reporting and follow-up of all adverse events (AE) reports for all Sandoz products from clinical trials, post-marketing studies (PMS), Patient Oriented Programs (POP), registries and all Spontaneous Reports (SR).
- Transcribe, translate (where required) and enter data of all Serious Adverse Events (from Clinical Trials,) and all adverse events (from POPs, PMS, registries and all SRs) from source documents onto safety systems accurately and consistently with emphasis on timeliness and quality.
- Record and track receipts, submissions and distributions of documents like SAEs, SRs, Investigator Notifications etc in cooperation with other departments -Manage reporting/submission/distribution of safety reports/updates/information to Local Health Authorities and/or clinical operations in cooperation with other Departments.
- Work with other local/global PV associates to ensure accurate evaluation of safety data.
- Interact and exchange relevant safety information with LHA, PV associates, other functional groups and third party contractor, if applicable.
- Survey and monitor general/ regional/national (as applicable)



pharmacovigilance regulations and provide update to global PVO organization.
- Develop, update and implement local procedures to ensure compliance with PVO global procedures and national requirements.
- Management and maintenance all relevant assigned PVO databases, if applicable.
- Develop and update training materials for pharmacovigilance -Ensure support for and close-out of audits, corrective action plan activities and Health Authority inspections.
- Provide timely, relevant information to trial coordinators, CRAs and other Sandoz staff -Distribution of marketing samples (where applicable)
**Key performance indicators**:
- Adherence to Sandoz policy and guidelines -Project and stakeholder feedback -Operational risk mitigation and audit/inspection findings -Quality and timely reporting of KPI and safety reports/updates -Results of audits/inspections
**Minimum Requirements**:
**Work Experience**:
- Functional Breadth.
- Collaborating across boundaries.
- Operations Management and Execution.
**Skills**:
- Databases.
- Employee Training.
- Filing (Documents).
- Pharmacovigilance.
- Reporting.
- Safety Science.
**Languages**:
- English.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Join us!
Commitment To Diversity & Inclusion (hard Coded In Workday)

📌 Patient Safety Specialist (Baja California Sur)
🏢 Sandoz
📍 Baja California Sur